Psychosocial Support in Treating Women With Recurrent Breast Cancer or Stage I, Stage II, or Stage IV Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00416780
Recruitment Status : Completed
First Posted : December 28, 2006
Last Update Posted : May 30, 2013
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Meeting together with other breast cancer patients to receive psychosocial support and to learn to reduce stress may help patients cope with their diagnosis, have a better quality of life, and live more comfortably.

PURPOSE: This randomized clinical trial is studying how well psychosocial support works in treating women with recurrent breast cancer or stage I, stage II, or stage IV breast cancer.

Condition or disease Intervention/treatment Phase
Breast Cancer Psychosocial Effects of Cancer and Its Treatment Other: counseling intervention Other: educational intervention Procedure: psychosocial assessment and care Not Applicable

Detailed Description:


  • Evaluate theoretically derived psychosocial interventions (peer discussion support vs education and stress management vs usual-care control) targeted to enhance adjustment and functional status and lower morbidity among women diagnosed with and treated for recurrent or stage I, II, or IV breast cancer.
  • Evaluate the psychological, behavioral, and biological pathways and their effects in patients treated with these interventions.
  • Evaluate the efficacy of these intervention in these patients.
  • Evaluate the nature and extent of coping strategies in these patients.
  • Evaluate the differences in patients treated with these intervention vs those patients electing not to be treated with these interventions.

OUTLINE: This is a randomized study. Patients are stratified according to disease stage (early vs late). Patients with early-stage disease are randomized to 1 of 3 intervention arms. Patients with late-stage disease are randomized to 1 of 2 intervention arms (II or III).

  • Arm I (education and stress management): Patients undergo a 1-hour group (6-10 patients per group) education session once a week for 8 weeks focusing on exchange of factual information between a facilitator and patients. The session includes a 45-minute lecture, discussing risks, diagnosis, and treatment of cancer; side effects from treatment; nutrition during treatment; and follow-up care, followed by a question/answer period and instruction in progressive relaxation techniques. Patients then receive 3 monthly phone calls from a project staff member to answer questions about cancer, treatment, and follow-up care and to discuss the relaxation exercises.
  • Arm II (peer discussion): Patients undergo a 1-hour group (6-10 patients per group) peer support session once a week for 8 weeks focusing on the provision of emotional support among patients and the maintenance of purpose in life. The session emphasizes on the sharing of experiences, the development of a common bond, and the promotion of altruism to similar others. Patients then are given an opportunity to attend 3 monthly additional meetings to share critical experiences and problems they have experienced in the past month.
  • Arm III (control): Patients receive usual care and are not asked to attend any meetings.

All patients undergo a 2-hour baseline interview, a 1.5-hour post intervention interview, and a 1.5-hour final interview 8 months after randomization.

PROJECTED ACCRUAL: A total of 350 patients will be accrued for this study.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Primary Purpose: Supportive Care
Official Title: Psychobiological Pathways: Breast Cancer Interventions
Actual Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • Diagnosed with breast cancer

    • First-time diagnosis of stage I or II disease

      • No more than 2 months since prior breast cancer surgery
    • Initial diagnosis of stage IV disease
    • Distant recurrence of prior breast cancer
  • Hormone receptor status not specified


  • Female
  • Menopausal status not specified
  • Reside within a 60-mile radius of the greater Pittsburgh metropolitan area


  • See Disease Characteristics

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00416780

Sponsors and Collaborators
Pittsburgh Mind-Body Center at Carnegie Mellon University
National Cancer Institute (NCI)
Study Chair: Michael Scheier, PhD Pittsburgh Mind-Body Center at Carnegie Mellon University Identifier: NCT00416780     History of Changes
Other Study ID Numbers: PMBC-HS05-182
CMU-00000603 ( Other Identifier: cmu )
CDR0000459773 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: December 28, 2006    Key Record Dates
Last Update Posted: May 30, 2013
Last Verified: March 2006

Keywords provided by National Cancer Institute (NCI):
psychosocial effects of cancer and its treatment
recurrent breast cancer
stage I breast cancer
stage II breast cancer
stage IV breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases